Fmcna - Benton

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 51070 Based on observation and interview it was determined the facility failed to provide alcohol based antiseptic hand rub at three of four stations mounted in the treatment area and one of one station mounted in the waiting area. The failed practice did not allow patients and/or staff opportunities to perform non water based hand hygiene, thereby increasing the potential for spreading infection. The failed practice had the likelihood of affecting all 44 in-center hemodialysis patients on census. Findings follow: A. During a tour of the facility on 03/24/25 between 8:00 AM and 9:45 AM, the following was observed. 1. The waiting area had one “empty” alcohol based antiseptic hand rub station mounted on the wall for patient, visitor, and staff use. 2. The treatment area had three “empty” of four observed, alcohol based antiseptic hand rub station mounted on the wall for patient, visitor, and staff use. B. During an interview with the Director of Operations on 03/24/25 at 10:30 AM, the findings were confirmed.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 51070 Based on observation and interview it was determined staff failed to wear personal protective equipment (PPE) and/or remove PPE when exiting the treatment area. The failed practice did not prevent the transmission of infection. The failed practice had the likelihood of affecting all 44 in-center hemodialysis patients. A. A review of policy titled “Personal Protective Equipment” dated 11/06/23, showed that PPE must be worn to protect employees from blood or other potentially infectious materials. Also, “all PPE shall be removed prior to leaving the treatment area”. B. During a tour of the facility on 03/24/25 between 8:00 AM and 9:45 AM, one staff member was observed without personal protective equipment (PPE) in the treatment area while patients were receiving treatment, and two staff members were observed wearing PPE outside of the treatment area at the nurse’s station. C. During observation in the waiting area on 03/24/25 and again on 03/25/25, staff members were observed leaving the treatment area dressed in PPE to retrieve patients in the waiting area. D. During an interview with the Director of Operations on 03/25/25 at 1:00 PM, the findings in A-C were confirmed.”

“ENVIRONMENT-SCHEMATIC DIAGRAMS/LABELS CFR(s): 494.40(a) 8 Environment: schematic diagrams/labels Water systems should include schematic diagrams that identify components, valves, sample ports, and flow direction. Additionally, piping should be labeled to indicate the contents of the pipe and direction of flow. If water system manufacturers have not done so, users should label major water system components in a manner that not only identifies a device but also describes its function, how performance is verified, and what actions to take in the event performance is not within an acceptable range. This Standard is not met as evidenced by: 51070 Based on observation and interview, it was determined the facility failed to provide a schematic diagram or clear labels to identify components, valves, sample ports and directional flow of water. The failed practice did not allow staff to identify the components, valves, sample ports or directional flow of water to ensure proper functioning. The failed practice had the likelihood to affect all 44 in-center hemodialysis patients on census. A. During a tour of the facility on 03/24/25 between 8:00 AM and 10:45 AM, the water treatment system showed the following: 1. No schematic diagram was found to help staff identify the components, valves, sample ports and/or directional flow of the water for routine care or during an emergency. 2. All the tanks and lines throughout the water room were unlabeled or had damaged labels making it difficult to identify what the tank or line was for or the directional flow of water through the system. B. During an interview with the Area Technical Operations Manager and the Director of Operations on 03/24/25 at 9:30 AM the findings in A were confirmed.”

“SOFTENERS-AUTO REGENERATE/TIMERS/SALT LVL CFR(s): 494.40(a) 5.2.4 Softeners: auto regen/timers/salt/salt level Prior to exhaustion, softeners should be restored; that is, new exchangeable sodium ions are placed on the resin by a process known as “regeneration,” which involves exposure of the resin bed to a saturated sodium chloride solution. 5.2.4 Softeners Refer to RD62:2001, 4.3.10 Automatically regenerated water softeners: Automatically regenerated water softeners shall be fitted with a mechanism to prevent water containing the high concentrations of sodium chloride used during regeneration from entering the product water line during regeneration. The face of the timers used to control the regeneration cycle should be visible to the user. 6.2.4 Softeners Timers should be checked at the beginning of each day and should be interlocked with the RO system so that the RO is stopped when a softener regeneration cycle is initiated. The softener brine tank should be monitored daily to ensure that a saturated salt solution exists in the brine tank. Salt pellets should fill at least half the tank. Salt designated as rock salt should not be used for softener regeneration since it is not refined and typically contains sediments and other impurities that may damage O-rings and pistons and clog orifices in the softener control head. This Standard is not met as evidenced by: 51070 Based on observation and interview it was determined the facility failed to maintain an appropriately filled and sanitary brine tank in that the salt and water level was well below half-full and an unidentifiable brownish gray layer of residue was floating on top of the water. The failed practice had the likelihood of contaminating water used for dialysis treatment thereby spreading infection. The failed practice had the likelihood of affecting all patients receiving dialysis. A. During a tour of the facility on 03/24/25 between 8:00 AM and 9:45 AM, observation showed the brine tank was well below half-full of salt and water and showed a heavy buildup of brownish gray residue floating on top of the water. When asked what the brownish gray substance was, staff was unable provide identification of the substance. B. During an interview on 03/24/25 at 8:30 AM with the Charge Nurse and again at 10:30 with the Biomedical technician the findings were confirmed.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 51070 Based on observation, policy review, and interview, it was determined the facility failed to provide a functionally safe and secure entrance into the building, in that the front entrance was not in view of staff members either physically or through camera view, it lacked a door buzzer or other mechanism to alert staff to visitors, and the electronic doors were found to be turned off requiring patients, family members, and others to forcibly slide the front entrance door open; the entry foyer was cluttered with durable medical equipment (DME), and drop ceiling tiles were open and hanging over head. The failed practice did not allow for a safe or secure entry into the facility. The failed practice had the likelihood of affecting all patients, family members, and others entering the facility. Findings follow: A. A review of policy titled “Safety and Security in the Workplace, dated 12/15/20, showed “measures should be taken to ensure that every location within the company is secure and safe”. B. A review of policy titled “General Cleanliness and Infection Control Guidelines” dated 11/04/24, showed “all areas must be kept clean and organized” and “walkways must be kept clear of debris and free of clutter”. C. During a tour of the facility on 03/24/25 between 8:00 AM and 9:45 AM the following was observed at the front entrance area of the facility: 1) When attempting to enter the facility the front electronic doors were not functioning properly, and no buzzer or cameras were present to alert the staff to visitors entering the facility. Five patients and family members were observed forcibly sliding open the front entrance door to gain entry. One patient, using a walker, was observed entering the facility and had the door close on her causing her to stumble. 2) Four drop ceiling tiles were observed to be hanging open in the entrance. Small amounts of drop ceiling were found on the floor of the entrance under open/hanging drop ceiling tiles. 3) The entry foyer was observed to have stored durable medical equipment (DME) such as wheelchairs, walkers, and canes. 4) During an interview with the BioMed Technician on 03/24/25 at 9:30 AM, he confirmed the DME belonged to previous patients who no longer received treatment in the facility and should not be stored in the entryway. D. During an interview with the Area Technical Operations Director and the Director of Operations on 03/24/25 at 9:45 AM the findings in A-C were confirmed. Based on observation and interview, it was determined the facility failed to maintain a safe environment in that the door exiting the Water Treatment Room near the storage area had a gap at the bottom of the door exiting to the outside. The failed practice had the likelihood of allowing pests to enter the facility which promoted the spread of infection. The failed practice had the likelihood of affecting all 44 in-center hemodialysis patients on census. Findings follow: A. Observation on 03/24/25 at 8:15 AM showed a gap at the bottom of the door exiting Water Treatment Room near the storage area to the outside. B. During an interview with the Director of Operations on 03/25/25 at 10:30, the findings in A were confirmed. Based on observation, policy review, and interview, it was determined the facility failed to provide a safe, clean, and organized physical environment in four of four areas (Waiting Treatment Room, Treatment Area, Laboratory Room, Water Room which included a storage area and a Biohazard trash closet, and a Biomedical Office open to the treatment area) observed. The failed practice promoted the spread of infection and increased the likelihood of adverse events. The failed practice had the likelihood of affecting all 44 in-center hemodialysis patients. Findings follow: A. A review of policy titled “General Cleanliness and Infection Control Guidelines” dated 11/04/24, showed “all areas must be kept clean and organized” and “walkways must be kept clear of debris and free of clutter”. Additionally, “clean supplies may not be kept under sinks”. B. Observations on 03/24/25 between 8:00 AM and 9:45 AM showed the following findings throughout the facility: 1) There was a build-up of dirt, grime, rust, and white residue throughout the facility for example: a) The floors showed brown and black buildup throughout. b) All supply carts observed showed a heavy build-up of white residue. 2) The floors throughout the facility had unsealed areas with deep scratches and/or gouges in the tile. Additionally, there were missing baseboards with exposed areas of glue and a heavy buildup of dirt, dust, and grime on all of the floors throughout. 3) The doors to the treatment room, mechanical room, and water room were propped open upon entry into the facility which allowed for unauthorized entry into those areas. 4) Tape and tape residue was found throughout the facility. For example: a) Multiple taped signs were observed hanging in the waiting area. b) Multiple signs were taped to the cabinents and walls in the Treatment Area. c) Taped signs and heavy tape residue was observed on the bicarb, acid, and holding tanks in the Water Treatment Room. C. During an interview with the Area Technical Manager and the Director of Operations on 03/24/25 at 9:30 AM, the findings in A-B were confirmed Observation of the following areas on 03/24/25 between 8:00 AM and 9:45 AM showed the following: 1) Waiting Area: a) A cardboard box was stored on the floor in the middle of the waiting area creating a physical hazard that patients had to navigate around. b) The door to the Janitorial Closet which contained cleaning chemicals and supplies and was accessed through the waiting room was unlocked allowing for unauthorized entry into the closet. 2) Treatment Room: a) Five sinks with plexiglass splash guards were found to be cracked and/or chipped and heavily coated with dirt, grime, and white residue. b) The porcelain sink closest the Water Treatment Room was found to have a metal drainage tray containing fistuala clamps that were unlabeled making it difficult for staff to determine if they were clean or dirty. A heavy buildup of rust colored residue was found underneath the metal tray which had dripped down staining the porcelain with rust colored residue. c) Two standing metal cabinets containing supplies for patient use were found propped open. One of the two cabinets observed, next to Station #12, had the open door physically touching the dialyzer throughout a dialysis treatment. d) There was a hole in the wall behind dialysis Station #18. e) A wall panel behind dialysis Station #17 was found to be loose and buckled with moisture. f) The emergency evacuation kit, crash cart, patient supply cart, bicarb bottle cart, and trash cans were found to have heavy buildup of dirt, grime, and white residue. 3) The Lab Area had office supplies stored in the same room adjacent to where patient blood samples were processed and stored. 4) Water Treatment Room/Storage Area: a) Cardboard boxes were stored within approximately 6 inches of the ceiling and were blocking the front of the electrical panel in the storage area. Additionally, there were cardboard boxes stored on a wooden pallet. b) Dirt, dust, and grime were observed under and on the plastic and wooden pallets. c) The water system had heavy dirt, dust, grime, rust, and white buildup on all of the tanks, lines, motor housings, and pipes. d) There was trash on the floor under the acid tank and reverse osmosis (RO) system. e) There was a small cardboard box and several plastic caps stored on the pipes of the RO water system. f) A cart with 10 bicarb jugs were stored in front of the brine tank and showed heavy build-up of white residue, with 5 of 10 jugs observed missing caps leaving the jugs open to air. g) The ceiling directly above the water system had two large square access areas with unsealed plywood which showed dirt and dust. h) Two RO plastic blue filter covers showed deep scratches, dirt, grime, and sticky tape residue. i) A metal bracket, a squeegee, and a metal scraper, all with a rust-colored substance on them, were propped against tanks in the water system. 5) Biohazard Trash Room had red colored droplets on the wall throughout the room. 6) The Biomedical Office which was open to the treatment room had cardboard boxes stored on the floor, a sink with plastic bottles and cables stored in the sink, and a cardboard box of wet ceiling tiles leaned against the wall next to the sink. E. During an interview with the Area Technical Manager and the Director of Operations on 03/24/25 at 9:30 AM, the findings in A-D were confirmed.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 51070 Based on observation, review of policy, and interview it was determined the facility failed to maintain clean sanitary blood pressure (BP) cuffs for patient use, in that the hook portion of the Velcro was visibly soiled with a build-up of threads and debris which did not allow for effective cleaning and disinfection. The failed practice promoted the spread of infection from cross contamination. The failed practice had the likelihood of affecting all patients having their BP taken using these cuffs. Findings follow: A. A review of policy titled “General Cleanliness and Infection Control Guidelines” dated 11/04/24, showed all non-disposable equipment that touches intact skin shall be cleaned and disinfected. B. During observation of dialysis treatments on 03/25/25 between 8:30 AM and 10:30 AM showed BP cuffs at Stations # 4, #9, #11, and #18 had a build-up of threads and debris in the hook portion of the Velcro which did not allow for effective cleaning and disinfection between patients. C. During an interview with the Director of Operations on 03/25/25 at 1:00 PM the findings in A and B were confirmed. Based on observation and interview it was determined the facility failed to follow the manufacturers’ directions for use, in that it failed to dispose of 18 bottles of Prevnar pneumonia vaccine and 4 boxes (50 each) of butterfly needles, all beyond the manufacturers labeled expiration date. The failed practice did not allow the facility to ensure the vaccines potentcy, or that the integrity of the needles were guranteed. The failed practice had the likelihood of affecting all 44 in-center hemodialysis patients on census. Findings follow: A. During a tour of the facility on 03/24/25 between 8:00 AM and 9:45 AM, the following products were found to be beyond their manufacturers’ labeled expiration dates. 1) 18 bottles of Prevnar pneumonia vaccine in the locked Medication Refrigerator expired on 11/26/2022. 2) Two full boxes (50 each) of 21-gauge (G) butterfly needles used to draw blood samples for laboratory testing were expired 12/31/2024. 3) Two full boxes (50 each) of 23-G butterfly needles used to draw blood samples for laboratory testing one expired on 9/15/2024 and the other on 2/24/2025. B. During an interview with the Charge Nurse on 03/24/25 at 8:45 AM, the findings in A were confirmed.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 51070 Based on observation, policy review and interview, it was determined four (#3, #4, #11, and #17) of 22 patients observed were not in full view of direct patient care staff to ensure safety at all times in that their vascular access and blood lines were covered by blankets. The failed practice did not allow staff to assure the integrity of access sites, blood lines, or assure that needles had not become dislodged. The failed practice had the likelihood of affecting all 44 in-center hemodialysis patients on census. Findings follow: A. A reivew of policy titled “Patient Monitoring and Safety Checks During Hemodialysis Treatment” dated 09/05/23, showed that “patients must be under continual observation” and that safety checks include confirmation that each patient’s face and access remained uncovered. B. During a tour of the facility on 03/24/25 between 8:00 AM and 9:45 AM showed Patients (#3, #11, and #17) of were not in full view of staff in that their vascular access and blood lines were covered by blankets. Further, Patient #11’s head was covered from view. C. During an interview with the Charge Nurse on 03/24/25 at 8:15 AM, the findings in A and B were confirmed. D. During observation of dialysis treatments on 03/25/25 between 8:30 AM and 10:30 AM showed Patient #4 was not in full view, in that their access and blood line were covered. E. During an interview with the Director of Operations on 03/25/25 at 1:00 PM the findings in both A-D were confirmed.”

“PR-PRIVACY & CONFIDENTIALITY-TREATMENT CFR(s): 494.70(a)(3) The patient has the right to- (3) Privacy and confidentiality in all aspects of treatment; This Standard is not met as evidenced by: 44854 Based on policy review, observation, and interview, it ws determined the facility failed to provide a private location to discuss medical concerns with the Patient #4’s caregiver. The failed practice did not ensure Patient #4’s medical information remained confidential. The failed practice had the likelihood to affect all 44 patients on the census. Findings follow: A. Review of “HIPAA notice of Privacy Practices”, dated April 26, 2022, showed the facility is required by law to make sure the PHI (Personal Health Information) was kept private. B. During obersvation on 03/25/25 at 10:30 AM, Surveyor #1 observed the Charge Nurse was in the waiting room talking on the phone with Patient #4’s caregiver discussing the medical care of Patient #4 while a patient (waiting on treatment) was sitting in the chair next to Charge Nurse. C. During an interview on 03/25/25 at 11:30 AM, the Direcotr of Operations confirmed the findings in A.”

“PA-ASSESS CURRENT HEALTH STATUS/COMORBIDS CFR(s): 494.80(a)(1) The patient’s comprehensive assessment must include, but is not limited to, the following: (1) Evaluation of current health status and medical condition, including co-morbid conditions. This Standard is not met as evidenced by: 51070 Based on review of policy, medical record review, and interview it was determined the facility failed notify the physician or update the plan of care for two (#1 and #3) of six (#1-#6) patients reviewed that had early termination of treatments and one (#1) did not sign an “Against Medical Advice” (AMA) form that indicated the patient and/or legal representative understood the risk of early termination of treatment. The failed practice did not allow the patients to achieve their treatment goals and had the likelihood of affecting all 44 in-center dialysis patients on census. Findings follow: A. Review of the policy titled “Early Termination or Arriving Late for Treatment” dated 11/07/22, showed the Registered Nurse (RN) is “responsible to notify the physician and document on the AMA form” which includes a witnessed signature from the patient or legal representative indicating their understanding of the risk of early termination of treatment. B. A review of medical records for two (#1 and #3) of six (#1-#6) showed the following: a. Patient #1’s treatment was terminated on 03/22/25, 39 minutes early, evidence was requested that the patient and/or legal guardian was informed of the risk of early termination, or that an AMA form had been signed, and that the physician was notified. No evidence was provided. b. Patient #3’s treatment was terminated early on 03/15/25, 22 minutes early and again on 03/18/25, 47 minutes early; an AMA form was signed on both occasions, however, no evidence was provided with showed the physician had been notified or that the Interdisciplinary Team (IDT) had updated the Plan of Care. C. During an interview with the Charge Nurse and Director of Operation on 03/25/25 at 3:00 PM, the findings in A-B were confirmed.”